# Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies

> **NCT04648826** · PHASE1,PHASE2 · WITHDRAWN · sponsor: **National Cancer Institute (NCI)**

## Conditions studied

- Sarcomas
- Melanomas
- Germ Cell Tumors
- Epithelial Malignancies (Excluding Lung and Renal Cell Carcinomas)
- Pulmonary Metastases

## Interventions

- **DEVICE:** AeroEclipse II Breath Actuated Nebulizer
- **DRUG:** Bintrafusp alfa
- **DRUG:** Azacytidine

## Key facts

- **NCT ID:** NCT04648826
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2021-12-14
- **Primary completion:** 2021-12-14
- **Final completion:** 2021-12-14
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** Due to notification from EMD Serono, for Bintrafusp alfa (M7824) regarding an observed increase in the frequently of early progression and death.
- **Last updated:** 2021-12-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04648826

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04648826, "Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT04648826. Licensed CC0.

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